fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

Class I - Dangerous

💊 Drugs Recalled: November 12, 2019 QuVa Pharma Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
Lots: 10029972 Exp. 11/21/2019, 10030562 Exp. 11/28/2019, 10031447 Exp. 12/15/2019, 10031341 Exp. 12/15/2019, 10031630 Exp. 12/19/2019, 10031748 Exp. 12/22/2019, 10032817 Exp. 1/8/2020, 10033208 Exp. 1/19/2020, 10032887 Exp. 1/12/2020
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: QuVa Pharma, Inc.
Reason for Recall:: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

Product Codes/Lot Numbers:

Lots: 10029972 Exp. 11/21/2019, 10030562 Exp. 11/28/2019, 10031447 Exp. 12/15/2019, 10031341 Exp. 12/15/2019, 10031630 Exp. 12/19/2019, 10031748 Exp. 12/22/2019, 10032817 Exp. 1/8/2020, 10033208 Exp. 1/19/2020, 10032887 Exp. 1/12/2020